PopART is a community randomized trial that is investigating whether a community-wide combination HIV prevention package including annual home-based HIV testing, active referral and the offer of immediate ART for those testing HIV-positive, along with the promotion of proven HIV prevention methods (such as voluntary medical male circumcision, prevention of mother to child transmission and condom use), will help to prevent transmission and substantially reduce new HIV infections. The study is being conducted in 21 communities in Zambia and South Africa (randomized into 3 arms, each with 7 communities) with a total population of approximately 1.2 million individuals.

Population Effects of Antiretroviral Therapy to Reduce HIV Transmission (PopART): A Cluster-randomized Trial of the Impact of a Combination Prevention Package on Population-level HIV Incidence in Zambia and South Africa

The number of adults (16 years and older) in the household and the number of HIV tests performed as indicated in data from CHiP teams and health centers

Time between HIV diagnosis and initiation of care [ Time Frame: 3 years ]

The proportion of Population Cohort members initiating HIV care within 3 months of a positive HIV diagnosis

The proportion of community members initiating HIV care within 3 months of HIV diagnosis as indicated in data from CHiP teams (provision of HIV positive result) and health center data (date of care initiation)

o House-to-house deployment of: Universal HIV counseling and testing; Active linkage to care for individuals diagnosed as HIV-infected, with immediate eligibility for ART; Promotion of male circumcision and prevention of mother to child transmission (PMTCT) services; Provision of condoms; Strengthening of HIV testing and services at health facilities and other venues; Strengthening of male circumcision and prevention of mother-to-child transmission of HIV services available in the community; and Treatment of sexually transmitted infections (STIs) and provision of condoms at health units

Other Names:

PopART Intervention

UTT

Active Comparator: Arm B ART according to National Guidelines

Other: Universal Testing with ART eligibility according to National Guidelines

Combination prevention package including:

House-to-house deployment of: Universal HIV counseling and testing; Active linkage to care for individuals diagnosed as HIV-infected, with ART eligibility according to national guidelines; Promotion of male circumcision and PMTCT services; Provision of condoms; Strengthening of HIV testing and services at health facilities and other venues; Strengthening of male circumcision and PMTCT services available in the community; and Treatment of STIs and provision of condoms at health units.

Other Name: PopART Intervention

Standard of Care

Includes:

Strengthening of HIV testing and ART services according to national guidelines at health facilities and other venues; Strengthening of male circumcision and PMTCT services available at health facilities and other venues in the community; and Treatment of STIs and provision of condoms at health facilities and other venues in the community.

Other: Standard of Care

Detailed Description:

HIV Prevention Trials Network (HPTN) 071 (PopART) will investigate the impact on HIV incidence of universal voluntary HIV counseling and testing (with referral to care) provided to a community through a house-to-house campaign, in combination with early ART for individuals who are HIV-positive, and other proven preventive interventions. The design of HPTN 071 (PopART) will allow the study team to distinguish between the impact of universal testing with referral for HIV care in accordance with national guidelines, and the impact of universal testing with referral for early ART initiation for those with HIV infection. In addition, HPTN 071 (PopART) will determine if a program of universal voluntary testing, including early ART initiation, is feasible and acceptable when delivered on a large scale to entire communities. Evaluating the effectiveness of universal voluntary HIV counseling and testing with the offer of early ART is a key global health priority.

Eligibility

Ages Eligible for Study:

18 Years to 44 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Population Cohort

18 - 44 years of age

Able and willing to provide informed consent

Residing within catchment area of a designated local health unit and intending to remain so for the next three years

Residing in a randomly selected household

Case-Control Study 1 Inclusion Criteria:

At least 18 years of age

Able and willing to provide informed consent

Resident in the cluster during the first round of testing

Visited by a CHiP team and offered testing during the first round of home-based testing

Case-Control Study 2 Inclusion Criteria:

At least 18 years of age

Able and willing to provide informed consent

Resident in the cluster during the first round of testing

Tested HIV-infected in CHiP home-based testing, or HIV-infected and disclosed that they were previously diagnosed as HIV-infected to CHiP team

Case-Control Study 3 Inclusion Criteria:

At least 18 years of age

Able and willing to provide informed consent

Resident in the cluster during the second round of testing

Visited by a CHiP team and offered testing during the second round of home-based testing

Exclusion Criteria:

Population Cohort Exclusion Criteria:

Current or planned enrollment in another HIV treatment, prevention, or Pre-Exposure Prophylaxis (PrEP) study

Current, planned or prior enrollment in an HIV vaccine study

Anything that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Case-Control Study 1 Exclusion Criteria:

Individuals belonging to the Population Cohort or other case-control studies

Individuals known to be HIV-infected after testing elsewhere.

Case-Control Study 2 Exclusion Criteria:

Individuals enrolled in the Population Cohort or other case-control studies

HIV-infected individuals already on ART before study commences

Case-Control Study 3 Exclusion Criteria:

Known HIV infected from CHiP data.

Individuals belonging to the Population Cohort or other case-control studies

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900977